GONAL-f\u00ae<\/p>\n
Follitropin alfa<\/p>\n
Solution for injection, 300 IU (22 mcg)\/0.5 mL, 450 IU (33 mcg)\/0.75 mL, 900 IU (66 mcg)\/1.5 mL<\/p>\n
One pre-filled pen contains<\/p>\n
active substance \u2014 follitropin alfa (recombinant human follicle-stimulating hormone) 22 mcg, 33 mcg, 66 mcg,<\/p>\n
excipients: poloxamer 188, sucrose, methionine, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate dihydrate, m-cresol, concentrated phosphoric acid, sodium hydroxide, water for injection.<\/p>\n
Colorless or pale yellow, clear or slightly opalescent solution.<\/p>\n
Sex hormones and modulators of the genital system. Gonadotropins and other ovulation stimulants. Gonadotropins. Follitropin alfa.<\/p>\n
ATC code G03GA05<\/p>\n
Pharmacokinetics<\/strong><\/em><\/p>\n Following subcutaneous administration, the absolute bioavailability of follitropin alfa is approximately 70%. Following repeated administration, follitropin alfa accumulates and steady state is reached within 3\u20134 days. One eighth of the follitropin alfa dose is excreted in the urine.<\/p>\n Pharmacodynamics<\/p>\n GONAL-f\u00ae is a follicle-stimulating hormone (FSH) preparation produced using recombinant DNA technology.<\/p>\n In women, the most important effect of parenteral FSH administration is the development of mature Graafian follicles.<\/p>\n In clinical studies, patients with severe FSH and luteinizing hormone (LH) deficiency were defined by serum endogenous LH levels < 1.2 IU\/L. However, it should be taken into account that LH measurements may vary between laboratories.<\/p>\n GONAL-f\u00ae, administered in combination with human chorionic gonadotropin (hCG) for at least 4 months, induces spermatogenesis in men with FSH deficiency.<\/p>\n \u2014 anovulation (including polycystic ovary syndrome) in women who have failed to respond to treatment with clomiphene citrate<\/p>\n \u2014 stimulation of multiple follicular development in patients undergoing superovulation prior to assisted reproductive technologies (ART), such as in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), and zygote intrafallopian transfer (ZIFT)<\/p>\n \u2014 stimulation of follicular development in women with severe luteinizing hormone and follicle-stimulating hormone deficiency (in combination with a luteinizing hormone (LH) preparation)<\/p>\n \u2014 stimulation of spermatogenesis in men with congenital or acquired hypogonadotropic hypogonadism (in combination with a human chorionic gonadotropin (hCG) preparation)<\/p>\n Treatment with the medicinal product should be initiated under the supervision of a physician experienced in the treatment of infertility. The medicinal product is intended for subcutaneous administration. The first injection should be administered under the direct supervision of a healthcare professional.<\/p>\n Anovulation (including polycystic ovary syndrome)<\/p>\n The medicinal product is administered as a course of daily injections. In menstruating patients, treatment should be started within the first 7 days of the menstrual cycle.<\/p>\n Treatment should be tailored to the individual patient\u2019s response, assessed by ultrasound examination of follicular size and\/or estrogen secretion levels. Treatment is usually initiated with a daily dose of 75\u2013150 IU FSH; if necessary, the dose may be increased by 37.5 IU (preferably) or 75 IU every 7 or 14 days (preferably) to achieve an adequate but not excessive response. The maximum daily dose generally does not exceed 225 IU FSH. If the patient does not respond adequately after 4 weeks of treatment, that treatment cycle should be discontinued, the patient should undergo further evaluation, and repeat treatment may then be recommended using a higher starting dose than in the previous cycle.<\/p>\n Once an optimal response has been achieved, a single injection of 250 mcg recombinant hCG (r-hCG) or 5,000\u201310,000 IU hCG should be administered 24\u201348 hours after the last GONAL-f\u00ae injection. The patient is advised to have sexual intercourse on the day of hCG administration and on the following day. Alternatively, intrauterine insemination may be performed.<\/p>\n If an excessive response occurs, treatment should be discontinued and hCG administration should be withheld. In the following cycle, treatment should be initiated at a lower dose than in the previous cycle.<\/p>\n Stimulation of multiple follicular development for superovulation prior to in vitro fertilization or ART<\/p>\n For superovulation, 150\u2013225 IU of the medicinal product is generally administered daily starting on day 2 or 3 of the cycle. Treatment is continued until adequate follicular development is achieved, as assessed by serum estrogen concentrations and\/or ultrasound examination. The daily dose is adjusted according to the patient\u2019s ovarian response and should not exceed 450 IU. Adequate follicular development is usually achieved on approximately the tenth day of treatment on average (range: 5 to 20 days).<\/p>\n To induce final follicular maturation, a single injection of 250 mcg r-hCG or 5,000\u201310,000 IU hCG should be administered 24\u201348 hours after the last GONAL-f\u00ae injection.<\/p>\n To suppress the endogenous LH surge and maintain tonic LH levels, desensitization with gonadotropin-releasing hormone (GnRH) agonists or antagonists is commonly used. According to a generally accepted treatment protocol, GONAL-f\u00ae is started approximately 2 weeks after the initiation of agonist treatment, and both medicinal products are continued until adequate follicular development is achieved. For example, after 2 weeks of agonist treatment, 150\u2013225 IU of GONAL-f\u00ae is administered during the first 7 days. The dose is then adjusted according to the patient\u2019s ovarian response.<\/p>\n Overall experience with IVF indicates that treatment success rates generally remain stable during the first four treatment cycles and then gradually decline.<\/p>\n Stimulation of follicular development in women with severe LH and FSH deficiency<\/p>\n In women with severe LH and FSH deficiency (hypogonadotropic hypogonadism), GONAL-f\u00ae is administered as a course of daily injections together with lutropin alfa. Since these patients have amenorrhea and low endogenous estrogen secretion, treatment may be started at any time.<\/p>\n Treatment should be tailored to the individual patient\u2019s response, assessed by ultrasound examination of follicular size and\/or estrogen secretion levels. It is recommended to begin treatment with 75 IU lutropin alfa daily in combination with 75\u2013150 IU FSH.<\/p>\n If necessary, the FSH dose may be increased at 7\u201314-day intervals by 37.5\u201375 IU. The duration of stimulation within a single cycle may be extended up to 5 weeks.<\/p>\n Once an optimal response has been achieved, a single injection of 250 mcg r-hCG or 5,000\u201310,000 IU hCG should be administered 24\u201348 hours after the last GONAL-f\u00ae and lutropin alfa injections. The patient is advised to have sexual intercourse on the day of hCG administration and on the following day. Alternatively, intrauterine insemination may be performed.<\/p>\n Luteal phase support may be required during treatment, since a deficiency of compounds with luteotropic activity (LH\/hCG) after ovulation may lead to premature corpus luteum insufficiency.<\/p>\n If an excessive response occurs, treatment should be discontinued and hCG administration should be withheld. In the following cycle, treatment should be initiated with a lower dose of GONAL-f\u00ae than in the previous cycle.<\/p>\n Men with hypogonadotropic hypogonadism<\/p>\n The medicinal product is administered at a dose of 150 IU three times a week in combination with hCG for at least 4 months. If no positive effect is observed at the end of this period, combination treatment should be continued for at least 18 months.<\/p>\n Elderly patients<\/p>\n Since there are no indications for the use of GONAL-f\u00ae in elderly patients, the efficacy and safety of the medicinal product in this patient population have not been established.<\/p>\n Patients with renal or hepatic impairment<\/p>\n The efficacy and safety of the medicinal product in patients with renal or hepatic impairment have not been established.<\/p>\n Children<\/p>\n GONAL-f\u00ae is not used for the treatment of children.<\/p>\n If the patient administers GONAL-f\u00ae independently, the instructions below should be carefully read and followed:<\/p>\n General recommendations<\/p>\n Self-administration should only be performed by properly trained patients who are able to consult a physician if necessary. During patient training for self-administration, particular attention should be paid to the specific instructions for use of the pre-filled pens. Daily injections are recommended at approximately the same time each day, changing the injection site daily. It should be ensured that patients always have a sufficient number of pens available for the prescribed treatment regimen.<\/p>\n Pre-filled pens are intended for use by one patient only and are not designed for cartridge replacement.<\/p>\n Prepare the pre-filled GONAL-f\u00ae pen and administer the prescribed dose as described below. Do not administer the solution if it is not clear or contains foreign particles.<\/p>\n Trade Name GONAL-f\u00ae International Nonproprietary Name Follitropin alfa Dosage Form Solution for injection, 300 IU (22 mcg)\/0.5 mL, 450 IU (33 mcg)\/0.75 mL, 900 IU (66 mcg)\/1.5 mL Composition One pre-filled pen contains active substance \u2014 follitropin alfa (recombinant human follicle-stimulating hormone) 22 mcg, 33 mcg, 66 mcg, excipients: poloxamer 188, sucrose, methionine, sodium dihydrogen […]<\/p>\n","protected":false},"featured_media":0,"menu_order":0,"template":"","class_list":["post-618","pharmacy_product","type-pharmacy_product","status-publish","has-post-thumbnail","hentry"],"yoast_head":"\nIndications for Use<\/h3>\n
Method of Administration and Dosage<\/h3>\n
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